FDA programs hurt by budget crunch

WASHINGTON — When scientific advisers urged the Food and Drug Administration (FDA) in February to put a strong warning about suspected heart risks on attention-deficit drugs taken by millions of children and adults, agency officials said more clinical evidence was needed.

Now, the FDA-funded study meant to answer questions about the drugs for attention deficit-hyperactivity disorder may be halted. The reason: The agency doesn't have the money to finish the study.

The threat to the study, as disclosed in documents and interviews, stems from the chronic shortchanging of the nation's drug-safety program. It is one symptom of a federal agency increasingly constrained by a budget that has failed to keep up with costs.

As concerns grow, the agency has budgeted only $1.6 million for such safety studies of medications already on the market; that sum is scheduled to drop to $900,000 in the coming year. Outside experts estimate the agency needs $20 million to $100 million a year to conduct such studies.

Recently, three former secretaries of Health and Human Services sounded a public alarm about what they see as a dangerous squeeze on the overall FDA budget. Tommy Thompson, who served in President Bush's first term; Donna Shalala, who served under President Clinton; and Louis Sullivan, who served under President George H.W. Bush, joined consumer and industry groups calling on the administration to substantially boost the agency's $1.5 billion annual budget.

The agency acknowledged in a statement that more money is needed for safety and noted that funding to complete the study on attention deficit-hyperactivity disorder, or ADHD, "has not yet been identified."

A special fact-finding panel of the Institute of Medicine recently put the troubles in blunt terms in a report that called for significant FDA changes.

Funding for drug safety is "especially inadequate [and] resource limitations have hobbled the agency's ability to improve and expand this essential component of its mission," the panel concluded.

FDA officials estimate the study of ADHD medications, including such well-known brands as Ritalin and Adderall, will cost between $2 million and $3 million. About $1 million has been committed to the investigation, being conducted by outside medical researchers.

By analyzing the records of thousands of individuals, the researchers will try to determine if the medications predispose patients to heart attacks and sudden death. Most ADHD drugs are derived from powerful stimulants. They help patients concentrate, but they also raise blood pressure, a major risk factor for heart disease and stroke.

Prescribed drugs

The medications, once given primarily to children, are increasingly prescribed for adults, a population more susceptible to heart problems. About 2.5 million children and 1.5 million adults take such medications.

The ADHD study is not the only example of a patchwork system.

The FDA bought — at a cost of $500,000 a year — a British database considered a state-of-the-art tool for drug-safety research. The General Practice Research Database contains complete medical records on 4 million patients that can be mined for information on reactions to drugs.

But the FDA has acknowledged its drug-safety office doesn't have enough professionals — epidemiologists, biostatisticians and computer programmers — to take full advantage of the database.

Seen as safety issue

The FDA's budget crunch has also hurt its ability to safeguard fresh produce, some critics say. That has become an issue in the aftermath of the E. coli outbreak traced to California spinach. The number of inspectors and field-office staff has been cut from 2,217 in 2003 to about 1,960.

"The agency is like a fire department running around with a little fire extinguisher," said Michael Jacobson, director of the Center for Science in the Public Interest, a nutrition-advocacy group. "The money situation for foods is probably worse than it's ever been."

A recent internal FDA analysis estimated the 2006 budget would have needed to be $2.2 billion, not $1.5 billion, just to keep pace with increases in personnel costs.

Second, the post-market drug-safety program — with a few exceptions — is not allowed to tap into user fees pharmaceutical companies pay the agency for the review of proposed new drugs. The user fees add about $400 million a year to the FDA's $1.5 billion budget.

Finally, compared to funding for the National Institutes of Health (NIH), which sponsors cutting-edge research, securing more money for the FDA has been a low priority for the administration and Congress. The NIH budget has increased from $20.5 billion in 2001 to $28.6 billion.

"There has been a dramatic increase in the attention focused on NIH, and we believe similar attention needs to be given to the FDA," said Sheila Burke, chairwoman of the Institute of Medicine panel that recently reported on drug safety.